{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T18:25:44Z","timestamp":1783535144752,"version":"3.55.0"},"reference-count":35,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T00:00:00Z","timestamp":1772236800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Introduction: High-output stoma (HOS) is a frequent and morbid complication following ileostomy formation. Proton pump inhibitors (PPIs) may reduce intestinal secretions, but no randomized trial has yet tested whether intensified intravenous omeprazole treatment prevents or mitigates early postoperative HOS. We aim to determine whether intensified PPI dosing reduces early postoperative ileostomy output compared with standard dosing. Methods and Analysis: STOP-HOS-1 is a randomized, parallel-group, open-label, superiority trial conducted at two academic centers in Poland. The target sample size is 100 adults undergoing the formation of a loop or end ileostomy. Participants will be randomized 1:1 to receive either: intensified omeprazole group\u201480 mg IV loading dose, followed by 40 mg IV twice daily through postoperative day (POD) 10, or standard omeprazole group\u201440 mg IV once daily through POD 10. The primary outcome is mean ileostomy output (mL\/24 h) across POD 1\u20133. A \u2265250 mL\/day reduction is prespecified as clinically meaningful. Key secondary outcomes include: incidence of HOS (\u22651000 mL\/day for \u22653 consecutive days or \u22651400 mL on any single day), time to output stabilization (&lt;1400 mL\/day for 3 consecutive days), dehydration-related complications (hyponatremia, hypokalemia, acute kidney injury), length of hospital stay and 30-day readmission rate. The primary analysis will follow the intention-to-treat principle. One interim safety analysis is planned after enrollment of the first 20 patients. Discussion: Although PPIs are commonly used to reduce ileostomy output, high-quality evidence in the early postoperative setting is lacking. STOP-HOS-1 targets the critical period when output is most variable, and complications are most frequent, using a pragmatic randomized design and an objective, clinically meaningful primary endpoint. Conclusions: STOP-HOS-1 will provide the first randomized evidence on whether intensified postoperative PPI therapy reduces early ileostomy output and HOS-related morbidity, informing future standards of care.<\/jats:p>","DOI":"10.3390\/jcm15051841","type":"journal-article","created":{"date-parts":[[2026,3,2]],"date-time":"2026-03-02T10:24:34Z","timestamp":1772447074000},"page":"1841","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Study of Treatment with Intensified Omeprazole to Prevent High-Output Stoma\u2014A Protocol for a Randomized, Parallel-Group, Open-Label, Superiority Trial in Adults Undergoing Ileostomy (STOP-HOS-1)"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3868-7955","authenticated-orcid":false,"given":"Tomasz","family":"Sylwestrzak","sequence":"first","affiliation":[{"name":"Department of Gynecology and Obstetrics, Medical University of Gda\u0144sk, M. Sk\u0142odowskiej-Curie 3a Street, 80-210 Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0206-5275","authenticated-orcid":false,"given":"Michalina","family":"Ciosek","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gda\u0144sk, M. Sk\u0142odowskiej-Curie 3a Street, 80-210 Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katarzyna","family":"Po\u0142omska","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gda\u0144sk, M. Sk\u0142odowskiej-Curie 3a Street, 80-210 Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaros\u0142aw","family":"Kobiela","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gda\u0144sk, M. Sk\u0142odowskiej-Curie 3a Street, 80-210 Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7111-4660","authenticated-orcid":false,"given":"Piotr","family":"Spychalski","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gda\u0144sk, M. Sk\u0142odowskiej-Curie 3a Street, 80-210 Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,28]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1097\/SLA.0b013e3180603024","article-title":"Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: A randomized multicenter trial","volume":"246","author":"Matthiessen","year":"2007","journal-title":"Ann. Surg."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1186\/s13017-018-0192-3","article-title":"2017 WSES guidelines on colon and rectal cancer emergencies: Obstruction and perforation","volume":"13","author":"Pisano","year":"2018","journal-title":"World J. Emerg. 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